Flowonix Medical recalls Prometra II Programmable Pumps (Cat. No. 13827) for intrathecal infusion due to unexpected shutdowns when Error 115 occurs, caused by software defects from improper programming with Clinician Programmer v2.00.29.
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.
Flowonix Medical is recalling Prometra II Programmable Pumps (Cat. No. 13827) for intrathecal infusion because a software defect can cause the pump to shut down unexpectedly when Error 115 is triggered. This error occurs if healthcare providers use a Clinician Programmer version 2.00.29 to program a Bridge or Demand bolus while the pump is set to Periodic Flow or Multiple Rates mode, or if dendrites form or the pump is dropped.
The pump can shut down unexpectedly when Error 115 occurs, which is caused by a software defect. This defect happens when healthcare providers use Clinician Programmer version 2.00.29 to program a Bridge or Demand bolus while the pump is set to Periodic Flow or Multiple Rates mode. The error can also occur if dendrites form or if the pump is dropped.
Healthcare providers who use the Prometra II Programmable Pump (Cat. No. 13827) for intrathecal infusion are most at risk if they have programmed it with Clinician Programmer version 2.00.29 while the pump was set to Periodic Flow or Multiple Rates mode. Patients using the pump are also at risk if the pump is dropped or dendrites form.
Check your Prometra II Programmable Pump (Cat. No. 13827) for intrathecal infusion serial numbers listed in the recall: 10AA4A01X, 10BC4A84X, 10CC4C06X, and other serial numbers provided in the recall notice.
Look for the serial number on your pump, which should match one of the listed serial numbers in the recall (e.g., 10AA4A01X, 10BC4A84X, 10CC4C06X).
If your pump shuts down unexpectedly with Error 115, stop using it immediately and contact Flowonix Medical.
Error 115 is an alarm associated with a watchdog timer timeout that can cause the pump to shut down unexpectedly.
Your pump is affected if it has the serial numbers listed in the recall, such as 10AA4A01X, 10BC4A84X, or 10CC4C06X, and if it was programmed with Clinician Programmer version 2.00.29 while set to Periodic Flow or Multiple Rates mode.
Stop using the pump immediately and contact Flowonix Medical for further instructions.
We’ve drafted a message you can send Flowonix Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1715-2019 — Flowonix Medical Flowonix Medical Hello, I own a Flowonix Medical that is covered by recall Z-1715-2019 from Flowonix Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
